Kamaptin

Package Leaflet: Information for the User

Kamaptin, 10 mg, hard capsules

Kamaptin, 18 mg, hard capsules

Kamaptin, 25 mg, hard capsules

Kamaptin, 40 mg, hard capsules

Kamaptin, 60 mg, hard capsules

Kamaptin, 80 mg, hard capsules

Kamaptin, 100 mg, hard capsules

Atomoxetine

Read this carefully before taking Kamaptin

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What is Kamaptin and what is it used for
• 2. Before you take Kamaptin
• 3. How to take Kamaptin
• 4. Possible side effects
• 5. How to store Kamaptin
• 6. Contents of the pack and other information

1. What is Kamaptin and what is it used for

What Kamaptin is used for

Kamaptin contains atomoxetine and is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in:

• children over 6 years old
• adolescents
• adults

Kamaptin is used as part of a comprehensive treatment programme, which includes psychological, educational, and social measures. It is not a stimulant and is not habit-forming.

How Kamaptin works

Kamaptin increases the levels of a chemical called noradrenaline in the brain. This helps to improve attention and decrease impulsivity and hyperactivity in patients with ADHD.

About ADHD

Children and adolescents with ADHD have difficulty sitting still, paying attention, and controlling impulses. These problems can lead to difficulties at school, at home, and with friends.

Adults with ADHD may have difficulty with work, relationships, and low self-esteem.

2. Before you take Kamaptin

Do not take Kamaptin

Do not take Kamaptin if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Kamaptin.

Warnings and precautions

Serotonin syndrome is a potentially life-threatening condition that can occur when taking Kamaptin with certain other medicines.

• tell your doctor if you have any of the following: suicidal thoughts or behavior, heart problems, high blood pressure, liver problems, psychotic symptoms, mania, aggression, or a history of seizures

Kamaptin may cause serious side effects, including allergic reactions, heart problems, and liver damage.

Pregnancy and breast-feeding

Do not take Kamaptin if you are pregnant or breast-feeding, unless your doctor tells you to.

Driving and using machines

Kamaptin may cause drowsiness, dizziness, or fatigue. Be careful when driving or operating machinery.

Important information about the ingredients of Kamaptin

Do not open Kamaptin capsules, as the contents may irritate your eyes. If you get any of the contents in your eyes, rinse them with water and seek medical attention.

3. How to take Kamaptin

• Take Kamaptin exactly as your doctor or pharmacist has told you
• Children should not take Kamaptin without adult supervision
• Take Kamaptin once or twice a day, with or without food
• Swallow the capsules whole, do not open or chew them
• Take Kamaptin at the same time every day to help you remember

Dose

Children and adolescents (over 6 years old):

Your doctor will calculate the dose of Kamaptin based on your weight.

• Body weight up to 70 kg: the total daily dose is 0.5 mg/kg for at least 7 days, then your doctor may increase the dose to 1.2 mg/kg per day
• Body weight over 70 kg: the total daily dose is 40 mg for at least 7 days, then your doctor may increase the dose to 80 mg per day. The maximum daily dose is 100 mg

Adults:

• The total daily dose is 40 mg for at least 7 days, then your doctor may increase the dose to 80-100 mg per day. The maximum daily dose is 100 mg

If you have liver problems, your doctor may prescribe a lower dose.

If you take more Kamaptin than you should

If you take too much Kamaptin, contact your doctor or hospital immediately.

If you forget to take Kamaptin

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Kamaptin

Do not stop taking Kamaptin without talking to your doctor first.

Monitoring during treatment

Your doctor will monitor your progress, including your blood pressure and heart rate, and may perform other tests.

4. Possible side effects

Like all medicines, Kamaptin can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people) include:

• headache
• abdominal pain
• decreased appetite
• nausea or vomiting
• drowsiness
• increased blood pressure
• increased heart rate

Common side effects (may affect up to 1 in 10 people) include:

• irritability or mood swings
• sleep disturbances
• depression
• anxiety
• tics
• dizziness
• constipation
• diarrhea
• skin rash

Uncommon side effects (may affect up to 1 in 100 people) include:

• seizures
• psychotic symptoms
• aggression
• hostility
• mood swings

Rare side effects (may affect up to 1 in 1,000 people) include:

• liver damage

Very rare side effects (may affect less than 1 in 10,000 people) include:

• serious allergic reactions
• heart problems

If you experience any of the following, tell your doctor immediately

• dark urine
• yellowing of the skin or eyes
• abdominal pain
• unexplained nausea
• fatigue
• itching
• flu-like symptoms

5. How to store Kamaptin

Keep Kamaptin out of the sight and reach of children.

Do not use Kamaptin after the expiry date stated on the pack.

Do not store Kamaptin above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

6. Contents of the pack and other information

What Kamaptin contains

The active substance is atomoxetine hydrochloride.

• Each 10 mg capsule contains 10 mg atomoxetine
• Each 18 mg capsule contains 18 mg atomoxetine
• Each 25 mg capsule contains 25 mg atomoxetine
• Each 40 mg capsule contains 40 mg atomoxetine
• Each 60 mg capsule contains 60 mg atomoxetine
• Each 80 mg capsule contains 80 mg atomoxetine
• Each 100 mg capsule contains 100 mg atomoxetine

The other ingredients are microcrystalline cellulose and colloidal silicon dioxide.

What Kamaptin looks like and contents of the pack

Kamaptin capsules are available in 7, 28, or 56 capsules per pack.

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.

Manufacturer

Synoptis Industrial Sp. z o.o.

This medicinal product is authorised in the Member States of the European Economic Area

under the following names:

Spain: Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg ó 100mg cápsulas duras EFG

Germany: Atomoxetin Fairmed Healthcare 10mg, 18mg, 25mg, 40mg, 60mg, 80mg und 100mg Hartkapseln

Portugal: Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg ou 100mg cápsulas

Romania: ZENMET

Date of last revision of the leaflet: 24.01.2025